RANDOMIZED TRIAL OF 11-14 WEEK AMNIOCENTESIS AND TA CVS

11-14 周羊膜穿刺术和 TA CVS 的随机试验

• 批准号: 2673780
• 负责人: ELIZABETH ANN THOM
• 金额: $ 30.44万
• 依托单位: GEORGE WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-09-16 至 2000-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2673780
• 关键词: amniocentesis; chorionic villus sampling; clinical research; clinical trials; cytogenetics; diagnosis procedure safety; diagnosis quality /standard; embryo /fetus disorder; female; fluorescent in situ hybridization; gestational age; human pregnant subject; pregnancy loss; premature labor; prenatal diagnosis; rapid diagnosis; women's health

This application accompanies a proposal entitled "Randomized Trial of 11-14 Week Amniocentesis and TA CVS" submitted by Dr. Laird Jackson leading a group of twelve clinical centers. Together the proposals request funding for a multi-center randomized clinical trial of amniocentesis and transabdominal chorionic villus sampling (TA CVS) at 77-14 days gestation. This application proposes The George Washington University/Biostatistics Center as the Data Coordinating Center (DCC) for the study. The purpose of the study is to compare the two prenatal diagnosis techniques with regard to safety, measured primarily by a combined endpoint of fetal loss or preterm delivery before 196 days gestation and also by total fetal loss, amniotic fluid, gestational age at delivery, perinatal morbidity, neonatal morbidity and congenital abnormalities, including limb reduction effects. Success in obtaining a diagnosis from the two procedures will be compared. An ancillary study will evaluate the feasibility and accuracy of fluorescence in situ hybridization (FISH) as a rapid diagnostic method for certain cytogenetic abnormalities. A total of 6400 healthy pregnant women at 77 to 104 days gestation, whose only indication for prenatal diagnosis is advanced maternal age of at least 34 years at enrollment or trisomy in a previous pregnancy will be randomized to receive either TA CVS or amniocentesis following a baseline ultrasound. Five thousand eligible women who refuse randomization or for whom a procedure cannot be scheduled by 104 days will also be followed, one thousand of whom will have a standard amniocentesis procedure. The DCC will assist the group in implementing the study by: (1) setting up a randomization procedure;' (2) training study personnel; (3) setting up a computerized data processing an editing system; (4) monitoring recruitment, protocol adherence and data quality; (5) preparing interim analyses of the results for a Safety monitoring Committee; (6) conducting final analyses and preparing the publication of results; and (7) documenting the final data base.

这项申请伴随着一项题为“11-14岁儿童的随机试验”的提案， 由Laird杰克逊博士领导的一个 12个临床中心。 这些提案共同要求提供资金 一项多中心随机临床试验， 妊娠77-14天经腹绒毛膜绒毛取样（TA CVS）。 本申请建议乔治华盛顿大学/生物统计学 中心作为研究的数据协调中心（DCC）。 的目的 本研究旨在比较两种产前诊断技术， 安全性，主要通过胎儿丢失或 妊娠196天前早产和胎儿完全丢失， 羊水，分娩孕周，围产期发病率，新生儿 发病率和先天性畸形，包括肢体减少的影响。 将比较两种手术的诊断成功率。 一项辅助研究将评估以下方法的可行性和准确性 荧光原位杂交（FISH）作为一种快速诊断方法， 某些细胞遗传异常 共有6400名妊娠77至104天的健康孕妇， 产前诊断的唯一指征是高龄产妇， 入组时年龄34岁或既往妊娠时为三体 基线后随机接受TA CVS或腹膜穿刺术 超声. 5000名符合条件的女性拒绝随机化或 如果一个程序不能在104天内安排， 其中上千人将接受标准穿刺术 发展协调委员会将通过以下方式协助小组实施研究： 建立随机化程序;（2）培训研究人员;（3） 建立计算机数据处理编辑系统;（4）监控 招募、方案依从性和数据质量;（5）准备临时 为安全监测委员会分析结果;（6）进行 最终分析和准备公布结果;以及（7） 记录最终数据库。